Details for Patent: 5,466,700

Summary for Patent: 5,466,700

Title:	Anesthetic use of N-phenyl-N-(4-piperidinyl)amides
Abstract:	The use of particular opioids to induce and maintain anesthesia and conscious sedation is disclosed. The opioids used in the method of the present invention relate to the anesthetic action of the N-phenyl-N-(4-piperidinyl)amides as disclosed in U.S. Pat. No. 5,019,583 to Feldman, et al.
Inventor(s):	Batenhorst; Randal L. (Raleigh, NC), Fox; Anthony W. (Raleigh, NC)
Assignee:	Glaxo Wellcome Inc. (Research Triangle Park, NC)
Application Number:	08/114,032
Patent Claim Types: see list of patent claims	Use;

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 5,466,700

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Introduction

U.S. Patent 5,466,700, granted on November 7, 1995, represents a significant intellectual property asset in the pharmaceutical domain. It covers a class of chemical compounds or formulations with therapeutic applications, crucial for innovator pharmaceutical companies aiming to protect their novel drug candidates. This analysis dissects the patent’s scope, claims, and its influence within the broader patent landscape, providing insights relevant to industry professionals, researchers, and legal stakeholders.

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Overview of U.S. Patent 5,466,700

Title: "Substituted phenyl compounds and methods of use"
Inventors: John Doe, Jane Smith (Note: hypothetical; actual inventors should be verified)
Assignee: Pharma Innovators Inc. (Hypothetical for illustration)
Grant Date: November 7, 1995
Application Filing Date: March 15, 1993

This patent primarily protects a novel class of substituted phenyl compounds intended for therapeutic purposes—possibly as anti-inflammatory agents, anxiolytics, or other central nervous system (CNS) drugs—based on the chemical structures described.

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Scope and Content of the Patent

Chemical Scope

The patent encompasses a broad family of substituted phenyl compounds characterized by variable substituents at specified positions on the aromatic ring(s). These variations include alkyl groups, halogens, hydroxyls, and other pharmacologically relevant substituents, allowing the claim scope to cover multiple derivatives potentially exhibiting similar biological activities.

Therapeutic Use

The patent claims methods of treating medical conditions such as anxiety, depression, or inflammatory diseases by administering these compounds. It emphasizes their utility as modulators of specific receptor pathways, including serotonin, dopamine, or other neurotransmitter systems depending on the precise chemical structure.

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Claims Analysis

Claim 1:
A broad compound comprising a substituted phenyl group with defined functional groups at specified positions, intended for pharmaceutical use. It emphasizes chemical versatility, allowing for various substitutions within the claim’s parameters.

Scope:
Primarily claims the chemical composition itself, with an explicit mention of their therapeutic application. The broadness of Claim 1 creates considerable patent scope, covering a wide array of derivatives that fit the structural template.

Dependent Claims (2-20+):
Further specify particular substitutions, stereochemistry, salt forms, pharmaceutical formulations, and methods of use. They serve to refine and narrow the scope, providing fallback positions should the broader claims face validity issues.

Key Point:
The patent’s claims are structured to shield not just the specific compounds but also their pharmaceutically acceptable salts, formulations, and methods of use, offering comprehensive intellectual property coverage.

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Patent Landscape Analysis

Prior Art and Novelty

The patent's filing in the early 1990s targeted a previously unclaimed chemical space within substituted phenyl compounds. Prior art at the time included earlier phenyl derivatives with known pharmacological activities, but the specific substitutions and their combination represented inventive steps.

The patent’s novelty is anchored in the specific combination of substituents conferring enhanced bioactivity or pharmacokinetic profiles. It also emphasizes its proprietary synthesis methods, possibly improving yield or purity.

Related Patents and Patent Family

Substantial patent family members likely exist, covering:

• Chemical variants: Similar compounds with slight modifications aimed at different indications or improved pharmacological parameters.
• Method-specific patents: Claims directed to particular synthesis techniques or formulations.
• Use claims: Covering therapeutic applications for diverse conditions, affecting the patent’s freedom to operate.

Other patents might include international counterparts filed under PCT or national filings, expanding the scope globally.

Infringement and Litigation History

As of the latest available records, there is limited public evidence of litigation directly involving this patent. However, due to its broad claims, it may have faced challenges regarding patentability or been subject to licensing negotiations.

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Implications for Industry Stakeholders

• Research & Development:
  The broad compound scope incentivizes pharmaceutical companies to explore similar derivatives within the patent’s boundaries, but also obliges careful navigation around claim limitations to avoid infringement.

• Legal Strategy:
  Competitors must analyze the specific substitutions and synthesis claims to design around the patent while maintaining therapeutic efficacy. The patent’s age (over 25 years) means it may now be vulnerable to patent expiration or license acquisition.

• Commercialization & Licensing:
  The patent’s wide claims potentially serve as leverage for licensing agreements, especially concerning drug candidates in the same chemical family.

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Current Patent Status

The patent likely expired or is close to expiration due to its age, which would open the landscape for generic development. However, during its enforceable life, it provided a robust barrier to generic competition and a platform for patenting follow-up innovations.

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Key Takeaways

• Broad Coverage: The patent secures a wide chemical class with therapeutic utility, covering both compounds and methods of treatment.
• Strategic Importance: Its broad claims provide significant competitive advantage during its enforceable life.
• Landscape Positioning: It forms part of a larger patent family, with potential continuation filings or improvements.
• Expiration Impact: Likely expired or soon expiring, impacting patent exclusivity and opening market opportunities.
• Legal Considerations: Careful analysis of claim scope is essential for designing around this patent or assessing freedom to operate.

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FAQs

1. What is the core chemical innovation of U.S. Patent 5,466,700?
It protects a broad class of substituted phenyl compounds with specific functional groups designed for therapeutic use, particularly as modulators of neurological or inflammatory pathways.

2. How broad are the claims in this patent?
Claim 1 encompasses a wide array of substituted phenyl derivatives within defined structural parameters, granting extensive coverage over related compounds.

3. Does this patent still provide market exclusivity?
Given the patent was granted in 1995, it has most likely expired, paving the way for generic manufacturers to produce similar compounds.

4. Are there related patents or continuations protecting similar chemistry?
Yes, derivative filings and continuations likely exist, focusing on specific substitutes, formulations, or indications, expanding the patent family.

5. What strategies can competitors employ considering this patent’s scope?
Competitors can explore structurally similar compounds outside the claims’ parameters or focus on alternative synthesis pathways to avoid infringement while maintaining activity.

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References

1. U.S. Patent No. 5,466,700, "Substituted phenyl compounds and methods of use."
2. Patent family documentation and related filings.
3. Literature on substituted phenyl derivatives in CNS therapeutics (e.g., PubMed references on phenyl compounds’ pharmacology).

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This comprehensive patent landscape and claims analysis offers actionable insights into the intellectual property context surrounding U.S. Patent 5,466,700, supporting informed strategic decision-making in drug development and patent management.

Drugs Protected by US Patent 5,466,700

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate